Jim joined Regenity in May 2026. He brings more than 25 years of leadership experience across FDA-regulated medical device organizations, with deep expertise spanning operations, research and development, and global regulatory, quality, and clinical functions. Most recently, he served as Senior Vice President, Global Quality, Regulatory Affairs, and Clinical Affairs at a leading global orthopedic device company, where he was responsible for enterprise-wide compliance, product lifecycle quality, and clinical strategy across a complex, multi-region organization.
Throughout his career, Jim has demonstrated a strong track record of driving operational excellence and strengthening quality and regulatory systems in highly regulated environments. He has led global organizations through significant regulatory change, including implementation of EU MDR, while maintaining strong compliance and enabling business growth. Jim’s experience includes leading regulatory strategy, overseeing clinical evidence generation, and ensuring robust quality systems that support both innovation and commercialization.
Education:
Jim holds a Bachelor of Science degree in Electrical and Computer Engineering from Valparaiso University.
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It’s great to be part of a company that is focused on making a positive difference in patient lives and doing it with the right core values. Regenity has a relentless pursuit to deliver the highest quality products and services to our customers, while maintaining a culture that puts the patient first.
Leadership Team
